# K982760: Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Nov 4, 1998 after 90 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993064: Prisma CFM (Continuous Fluid Management System) (1999), 9 descendants of its own
- K021615: Baxter Accura System, Model 5M5660 (2002), 8 descendants of its own
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets (2004), 4 descendants of its own
- K080519: Prismaflex M150 Set (2008), 1 descendant of its own
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01 (2007), 1 descendant of its own

## Indications for use
The COBE Cx Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration. The COBE Cx System may be used with both high permeability and low permeability (conventional) dialyzers. The COBE Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE Cx Hemodialysis Delivery System only.

Source page: https://510kreport.com/device/K982760
Methodology: https://510kreport.com/methodology